TX1 TISSUE REMOVAL SYSTEM
Instrument, Ultrasonic Surgical
AMERICAN OPTISURGICAL, INC.
The following data is part of a premarket notification filed by American Optisurgical, Inc. with the FDA for Tx1 Tissue Removal System.
Pre-market Notification Details
| Device ID | K101561 |
| 510k Number | K101561 |
| Device Name: | TX1 TISSUE REMOVAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Contact | David Salzberg |
| Correspondent | David Salzberg AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
Trademark Results [TX1 TISSUE REMOVAL SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TX1 TISSUE REMOVAL SYSTEM 85599103 not registered Dead/Abandoned |
Tenex Health, Inc. 2012-04-16 |
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